CE marking

CE marking is a requirement of the European Union when introducing medical devices, personal protective equipment and in vitro diagnostic medical devices into the European Union. CE marking is a procedure for conformity with a specific directive or regulation, which can be completed by a manufacturer’s declaration or by the assessment of a notified body depending on the risk class of the prod

Before placing on the market

In order to place a product on the market within the European Union, a number of requirements must be met, which are set out in European directives or regulations. The detailed requirements appear already at the design stage, through production, quality control and product registration.